Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for systematic review of measurement properties.

Background Patient centred healthcare is the corner stone to many healthcare strategies. Patient specific health needs should be at the fore of healthcare improvements and quality measurements. Patient reported outcome measures (PROM) that support real world clinical effectiveness assessments are increasingly being used to highlight domains where there is the greatest scope for change. Objectives This systematic review aims to identify and evaluate existing patient reported assessment measures/tool(s) that can be used in developing a PROM for postpartum women. We will assess and evaluate their measurement properties in a transparent and structured way in accordance with the COSMIN guidelines. Methods Methodological guidelines for systematic reviews of PROMs have been developed by the COSMIN initiative and will be followed for this systematic review. A systematic literature review will be performed using PubMed, CINAHL and EMBASE from inception to the present day. Two reviewers independently will judge eligibility, conduct data extraction and assess the methodological quality of each study as per COSMIN guidelines. Inclusion criteria: studies should concern PROM with an aim to evaluate measurement properties in the development or the evaluation of a PROM of interest. Included PROM will focus upon postpartum women assessing morbidity and quality of care. All peer reviewed studies with an assessment tool designed for patient completion will be considered. Exclusion criteria; abstract, letters and non-peer reviewed publications. Studies will be graded on measurement properties and quality of evidence as laid out by COSMIN. All studies and characteristics eligible for inclusion will be summarised and a recommendation to the most suitable measurement tool(s) will be given. Discussion We will provide a comprehensive description of all available patient reported assessment tools available for childbirth and postpartum quality of life and recommend based on COSMIN guidelines the most suitable instrument(s) available for use.

systematic review.A systematic literature review will be performed using PubMed, CINAHL and EMBASE from inception to the present day.Two reviewers independently will judge eligibility, conduct data extraction and assess the methodological quality of each study as per COSMIN guidelines.Inclusion criteria: studies should concern PROM with an aim to evaluate measurement properties in the development or the evaluation of a PROM of interest.Included PROM will focus upon postpartum women assessing morbidity and quality of care.All peer reviewed studies with an assessment tool designed for patient completion will be considered.Exclusion criteria; abstract, letters and non-peer reviewed publications.Studies will be graded on measurement properties and quality of evidence as laid out by COSMIN.All studies and characteristics eligible for inclusion will be summarised and a recommendation to the most suitable measurement tool(s) will be given.

Discussion
We will provide a comprehensive description of all available patient reported assessment tools available for childbirth and postpartum quality of life and recommend based on COSMIN guidelines the most suitable instrument(s) available for use.

Introduction
Patient-centric quality healthcare can only be developed with reliable information.Patient reported outcome measures (PROM) provide an insight into the impact that an intervention or therapy has on the patient, this is particularly important when striving for improvements in maternity care.PROM's support real world clinical effectiveness assessment for different care models and interventions, describe variation across sociodemographic and clinical groups, highlight domains where there is greatest scope for improvement, and detect variation between providers and institutions that cannot be explained by differences in case mix.There are no current means of capturing outcomes from the perspective of women receiving maternity care.The need for patient-reported outcome measures that can be used in maternity care has been gaining attention in the literature over the past decade.The CROWN initiative, an international initiative led by research journal editors which was established to standardise core outcomes reporting in women's health research has been calling for supporting PROM sets to be developed in tandem to their core outcome sets, but currently no maternity PROM exist [1][2][3] .
PROM are a means of assessing the impact that health events, and interventions have had on constructs such as quality of life.It is important to differentiate PROM from patientreported experience measures (PREMs).PREMs are assessments of the patients' experience of the care they received including whether certain standards of care were met, and their subjective satisfaction with care.There are multiple maternityspecific PREMs in Ireland and the UK: the Irish national maternity experience survey 4 and two in the UK, the national maternity services survey 5 and 'You and Your Baby' survey 6 .
The ideal PROM should have validity, reliability and be able to measure change over time 3 .Recent systematic reviews ascertained there are no PROM currently suitable for a maternity system, but many previously validated tools could be considered when designing a specific PROM for pregnancy and childbirth 2,7,8 .The development of a maternity PROM that covers antenatal, intra-partum, postpartum and neonatal care is challenging.There have been studies recently focusing on measures of recovery and recovery post Caesarean Section 9,10 .This project will focus on the generation of a maternity PROM focusing on delivery outcomes which can be applied to all women postpartum.Postpartum quality of life (QoL) will be examined across multiple domains.This includes but is not limited to the conceptual model of patient outcomes by Wilson and Cleary 11 ; symptom status → functional status → general health perception → overall QoL.This will allow new insights into women's perspectives of the healthcare they have received and ultimately driving the service into a more patient centred response.
The COnsensus-based Standards for the selection of health Measurement INstruments initiative has improved the selection and assessment of outcome measurement instruments.The COSMIN guidelines will allows us to select the best outcome measurements in a methodological and consistent way 12 .
'This study aims to identify and evaluate patient reported assessment measures/tool(s) that can be used in developing a PROM for postpartum women.Their measurement properties will be assessed in a transparent and structured way in accordance with the COSMIN guidelines.

Protocol and registration
The present paper is reported in accordance with the recommendations from the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P) statement 13 (see extended data) 14 .The review will follow COSMIN guidelines for systematic reviews 12 .This protocol has been submitted for registration with PROSPERO (submission number 283472).Details of the PROSPERO protocol registration will be provided in the final systematic review.

Search strategy
A systematic literature review to examine all available objective tools for patient assessment of QoL and health assessment after hospital based maternity care will be performed using the following bibliographic databases: PubMed, CINHAL and EMBASE.Databases will be searched from inception to present and there will be no language restrictions set.Additionally, hand searching of the reference lists of the studies included and key articles on this topic will be searched.
Using the comprehensive PROM filter developed for COSMIN 15 and with the assistance of a librarian a search thread was constructed as follows in order to identify all relevant publications (see extended data) 16 .The search thread included

Amendments from Version 2
The updated draft of the text after reviewer 3 comment includes more detailed information regarding the aims of the review and its eligibility and outcome criteria.The aims are now 'to identify and evaluate patient reported assessment measures/tool(s) that can be used in developing a PROM for postpartum women.'To further expand on the inclusion and outcome criteria for the review 'Eligible studies included generic and specific PROM that assessed postpartum women's health and wellbeing, where the study sample included >50% postpartum women as advised by COSMIN.The aim of the eligible study should be evaluation of one or more measurement properties of the tool, or the evaluation of the interpretability of the PROMs of interest.Studies that only use the PROM as a measurement instrument for the outcome of interest or in which the PROM was used for the validation of another instrument were excluded.Only full-text articles were included.All peer reviewed studies with an assessment tool designed for patient completion were considered.'Many thanks to the reviewers for their time and input into improving the clarity of this paper.
Any further responses from the reviewers can be found at the end of the article construct search, population search with a measurement properties filter and exclusion filter as recommended by COSMIN.We chose to not include a 'type of instrument' in our search strategy as it may possibly exclude potential tools of interest.
Selection of abstracts and full-text articles will be performed by two reviewers independently using Rayyan software.If there is a study that has been deemed relevant by at least one reviewer the full -text article will be retrieved and screened.If a consensus cannot be reached a third senior review will consult.

Eligibility criteria
The eligibility criteria for this review followed the COSMIN guidelines for systematic reviews of PROM recommendations.Eligible studies included generic and specific PROM that assessed postpartum women's health and wellbeing, where the study sample included >50% postpartum women as advised by COSMIN 12 .The aim of the eligible study should be evaluation of one or more measurement properties of the tool, or the evaluation of the interpretability of the PROMs of interest.Studies that only use the PROM as a measurement instrument for the outcome of interest or in which the PROM was used for the validation of another instrument were excluded.Only full-text articles were included.All peer reviewed studies with an assessment tool designed for patient completion were considered.

Data extraction
PRISMA-P guidelines and COSMIN guidelines for systematic reviews will be followed with the following steps being used to evaluate potential PROM 17 .These are a ten-step process as described in Figure 1.
The data to be extracted as recommended by the COSMIN systematic review guidelines 12 include the characteristics of the tool, characteristics about the population assessed, results on the measurement properties, which includes: structural validity, internal consistency, cross-cultural validity/measurement invariance, reliability, measurement error, criterion validity, hypotheses testing for construct validity, and responsiveness.'Information on the interpretability and feasibility will be assessed if available.This information will be extracted independently and presented in an overview table.If any information is missing the reviewers will contact the author for additional information.
Each study will we rated as very good, adequate, doubtful, or inadequate quality for the methodology used to assess the psychometric properties of that study.The overall rating of the quality of each study is determined by taking the lowest rating of any standard in the box (i.e."the worst score counts" principle).The results of each study on measurement property are rated against the criteria for a good measurement property.Each result is then rated as either sufficient (+), insufficient (-), or indeterminant (?) The results will be summarised using the modified GRADE approach.A modified GRADE approach will be used specifically for evaluating measurement properties in systematic reviews of PROM, the following four factors should be taken into account: (1) risk of bias (i.e. the methodological quality of the studies), ( 2) inconsistency (i.e.unexplained inconsistency of results across studies), (3) imprecision (i.e. total sample size of the available studies), and ( 4) indirectness (i.e.evidence from different populations than the population of interest in the review) Generating recommendations for the use of a PROM PRISMA-P guidelines and COSMIN guidelines for systematic reviews will be followed with the following steps being used to evaluate potential PROM 17 .These are a ten-step process as described in Figure 1.
The results on all available measurement properties will be quantitatively pooled or qualitatively summarised and against the criteria for good measurement properties to determine whether an overall measurement property is sufficient (+) insufficient (-) inconsistent (±) or indeterminant (?) for use.
A. PROMs with evidence for sufficient content validity (any level) AND at least low-quality evidence for sufficient internal consistency: recommended for use.
B. PROMs where further validation is needed.
C. PROMs with high-quality evidence for an insufficient measurement property: should not be recommended for use.

Dissemination of information
Publication in a leading journal.

Study status
Not started.

Discussion
A complete systematic assessment of the literature to examine available measurement properties is the first step toward developing a usable postpartum PROM.The COSMIN initiative aims to improve the selection of outcome measurement instruments in research and clinical practice by developing tools for selecting the most suitable instrument for the situation at issue and will be followed throughout this review.
Our aim is to recommend the best PROM or of combination of self-reported tool(s)/assessment measures to evaluate maternity care postpartum.Each step of the process will be reported on in a systematic and transparent way accompanied by clear recommendations for the most suitable outcome measurement instrument.The stated aim is to 'identify potential tool(s)/measurement that can be used to produce a PROM for postpartum women who have been given care within a maternity system'.This will be used to develop a maternity specific PROM with multiple domains.
Review question: This needs further clarification (and see comments on inclusion criteria below).Is the aim of the review to identify tools, or is the aim of the review to evaluate the psychometric properties of tools used to assess various measures of QoL in postpartum women?Is this specific part of the project to develop a new tool, or is this specific part of the project to assess what already exists, to take forward to produce a new tool?The review question should reflect this very specific aim.
Search strategy: 3 databases is very much the minimum expected for a systematic review.I would generally expect to see more databases searched, and to include the Cochrane library, plus PsychInfo as this is a review of psychometric properties.More supplementary searching should be included, for example, citation searching.
Inclusion criteria: Much more detail is need here.PICO isn't appropriate as childbirth isn't an 'intervention'.You could include it as an 'exposure', but as there is really no comparator -a PEO structure would be more relevant.
A section on 'types of study' would also be informative here.The protocol states that 'The study should concern PROM and finally the aim should be the evaluation of one or more measurement properties, the development of a prom or the evaluation of the interpretability of the PROM of interest.'I think further detail is needed on the types of PROM that are of interest.The authors have stated in the abstract that there are no maternity specific PROMs.Presumably these will still be searched for however -recent PROMs may have been published.In addition, more clarification is needed on what type of PROMs are expected to be included in light of the anticipated lack of condition-specific PROMs -i.e.generic PROMs such as EQ5D, SF-36 etc.So will the authors be retrieving studies which include the development/validation of generic tools, but only where they have been applied to maternity-specific populations?
For 'outcomes' -the authors state outcome is quality of care.Do they mean quality of life?However, isn't the outcome the psychometric properties of the tools that are being used to assess QoL?These properties as described in the COSMIN methodology should be briefly listed e.g.content validity; structural validity; internal consistency etc.
Finally, will the COSMIN ratings be ratified by subject experts and patients at the end of the process?
Is the rationale for, and objectives of, the study clearly described?Partly

Are the datasets clearly presented in a useable and accessible format? Not applicable evaluate the psychometric properties of tools used to assess various measures of QoL in postpartum women? Is this specific part of the project to develop a new tool, or is this specific part of the project to assess what already exists, to take forward to produce a new tool?
The review question should reflect this very specific aim.Response 1: Thank you, this systematic review aimed to both identify the tools available and to evaluate their psychometric properties.The objectives in the abstract read 'This systematic review aims to identify and evaluate existing patient reported assessment measures/tool(s) that can be used in developing a PROM for postpartum women.We will assess and evaluate their measurement properties in a transparent and structured way in accordance with the COSMIN guidelines.'The aim in introduction originally read 'The aim of this review is to identify potential tool(s)/measurement that can be used to produce a PROM for postpartum women who have been given care within a maternity system'.We have now edited it to read 'This study aims to identify and evaluate patient reported assessment measures/tool(s) that can be used in developing a PROM for postpartum women.Their measurement properties will be assessed in a transparent and structured way in accordance with the COSMIN guidelines.' Reviewer comment 2: Search strategy: 3 databases is very much the minimum expected for a systematic review.I would generally expect to see more databases searched, and to include the Cochrane library, plus PsychInfo as this is a review of psychometric properties.More supplementary searching should be included, for example, citation searching.Response 2: The search strategy states 'A systematic literature review to examine all available objective tools for patient assessment of QoL and health assessment after hospital based maternity care will be performed using the following bibliographic databases: PubMed, CINHAL and EMBASE.Databases will be searched from inception to present and there will be no language restrictions set.Additionally, hand searching of the reference lists of the studies included and key articles on this topic will be searched.'By searching these three databases we were hopeful that any articles on Cochrane or PsycInfo of relevance would be indexed in the above.This search strategy yields over 10,000 studies.Citation search will be included 'Additionally, hand searching of the reference lists of the studies included and key articles on this topic will be searched.'Reviewer comment 3: Inclusion criteria: Much more detail is need here.PICO isn't appropriate as childbirth isn't an 'intervention'.You could include it as an 'exposure', but as there is really no comparator -a PEO structure would be more relevant.Response 3:Thank you -we have changed the inclusion criteria section to read -'The eligibility criteria for this review followed the COSMIN guidelines for systematic reviews of PROM recommendations.Eligible studies included generic and specific PROM that assessed postpartum women's health and wellbeing, where the study sample included >50% postpartum women as advised by COSMIN.The aim of the eligible study should be evaluation of one or more measurement properties of the tool, or the evaluation of the interpretability of the PROMs of interest.Studies that only use the PROM as a measurement instrument for the outcome of interest or in which the PROM was used for the validation of another instrument were excluded.Only full-text articles were included.All peer reviewed studies with an assessment tool designed for patient completion were considered.' Reviewer Comment 4: A section on 'types of study' would also be informative here.The protocol states that 'The study should concern PROM and finally the aim should be the evaluation of one or more measurement properties, the development of a prom or the evaluation of the interpretability of the PROM of interest.'I think further detail is needed on the types of PROM that are of interest.Response 4: Thank you -we have changed the text in the Eligibility criteria to read -'Eligible studies included generic and specific PROM that assessed postpartum women's health and wellbeing, where the study sample included >50% postpartum women as advised by COSMIN.The aim of the eligible study should be evaluation of one or more measurement properties of the tool, or the evaluation of the interpretability of the PROMs of interest.Studies that only use the PROM as a measurement instrument for the outcome of interest or in which the PROM was used for the validation of another instrument were excluded.Only full-text articles were included.All peer reviewed studies with an assessment tool designed for patient completion were considered.'

Reviewer Comment 5:
The authors have stated in the abstract that there are no maternity specific PROMs.Presumably these will still be searched for however -recent PROMs may have been published.In addition, more clarification is needed on what type of PROMs are expected to be included in light of the anticipated lack of condition-specific PROMs -i.e.generic PROMs such as EQ5D, SF-36 etc.So will the authors be retrieving studies which include the development/validation of generic tools, but only where they have been applied to maternityspecific populations?Response 5: Thank you, any tool (generic or condition-specific) examining women's health and well-being postpartum will be included.The new Eligibility criteria text now reads 'Eligible studies included generic and specific PROM that assessed postpartum women's health and wellbeing, where the study sample included >50% postpartum women as advised by COSMIN.' Reviewer Comment 6 For 'outcomes' -the authors state outcome is quality of care.Do they mean quality of life?However, isn't the outcome the psychometric properties of the tools that are being used to assess QoL?These properties as described in the COSMIN methodology should be briefly listed e.g.content validity; structural validity; internal consistency etc. Response 6:Thank you -we have changed the inclusion criteria section to read -'Eligible studies included generic and specific PROM that assessed postpartum women's health and wellbeing, where the study sample included >50% postpartum women as advised by COSMIN.'The data extraction section reads 'The data to be extracted as recommended by the COSMIN systematic review guidelines include the characteristics of the tool, characteristics about the population assessed, results on the measurement properties' We have now added 'which includes: structural validity, internal consistency, cross-cultural validity/measurement invariance, reliability, measurement error, criterion validity, hypotheses testing for construct validity, and responsiveness.'Reviewer Comment 7:Finally, will the COSMIN ratings be ratified by subject experts and patients at the end of the process?Response 7: Thank you.The review will be conducted by subject matter experts, including obstetricians and gynaecologists actively involved in providing care at a tertiary-level maternity hospital and authors who have experience in designing and implementing PROM.The results of this systematic review will be Piloted by patients to better comprehend the recommended tools' content and validity, but patients will not be involved in the systematic review itself.This is an interesting and novel piece which aims to review existing PROMs and patient reported assessment measures and use this to develop a PROM for the post-partum period.
There are some small spelling errors that can be addressed through proofreading.
Only 2 databases will be searched -at least 3 are generally advised for a systematic review.Can the authors comment on this?
There is no sample search strategy given keywords, MESH headings, etc.This should be included in the protocol.

Are the datasets clearly presented in a useable and accessible format? Yes
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Diabetes in pregnancy and Patient-Reported Outcomes I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.
Author Response 10 Jan 2023

Laura O'Byrne
Thank you to the two reviewers for taking the time to review this protocol and for their comments.
Reviewer 2, comment 1 'Only 2 databases will be searched -at least 3 are generally advised for a systematic review.Can the authors comment on this?' Response: Thank you, we increased the search strategy to include searching on the CINAHL database.The search, therefore, included three databases PubMed, EMBASE and CINAHL which yielded 10,324 studies identified in the initial search, of which 29 tools were identified from 41 eligible studies included in the review.This has been added to the manuscript search strategy line 52 'A systematic literature review to examine all available objective tools for patient assessment of QoL and health assessment after hospital-based maternity care will be performed using the following bibliographic databases: PubMed, CINHAL and EMBASE.'The Abstract methods section has also been amended to include 'Methodological guidelines for systematic reviews of PROMs have been developed by the COSMIN initiative and will be followed for this systematic review.A systematic literature review will be performed using PubMed, CINAHL and EMBASE from inception to the present day.' Reviewer 2, comment 2: 'There is no sample search strategy given keywords, MESH headings, etc.This should be included in the protocol.'Response: The search strategy is included in the extended data held within the Harvard Dataverse: Search thread: Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for the systematic review of measurement properties.https://doi.org/10.7910/DVN/WMHKXG16.We thank you for your helpful comments that have improved the quality of the paper and thank you for re-considering this manuscript for review and publication.Thank you for this interesting and timely paper describing your systematic review protocol, to identify and evaluate PROMs for postnatal women.On the whole, the protocol seems appropriate and achievable.The rationale and objectives are clearly described, the proposed study design seems appropriate, and the proposed methods are described in detail.

Competing Interests: No competing interest
There are however, a few typos and it would be good to be consistent in the use of the acronym PROM/S/s.Also, the 3 paragraphs under the headings 'Data extraction' and 'Generating recommendations for the use of a PROM', seem to be a direct repeat.Good luck with the review and I look forward to seeing the results.I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Figure 1 .
Figure 1.The 10 steps for conducting a systematic review from the COSMIN manual for systematic reviews of patient reported outcome measures (PROMs) 12 .

Competing Interests: 1 Reviewer
No competing interests were disclosed.Reviewer Report 16 January 2023 https://doi.org/10.21956/hrbopenres.14957.r33331© 2023 Dickinson F. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Fiona Dickinson 1 Liverpool School of Tropical Medicine, Liverpool, UK 2 Liverpool School of Tropical Medicine, Liverpool, UK No new comments.Is the rationale for, and objectives of, the study clearly described?Not applicable Is the study design appropriate for the research question?Not applicable Are sufficient details of the methods provided to allow replication by others?Not applicable Are the datasets clearly presented in a useable and accessible format?Not applicable Competing Interests: No competing interests were disclosed.Reviewer Expertise: Development of PROMs for use in maternity services in low and middleincome countries; Emergency obstetric care in LMIC; Care of mothers and newborns in LMIC.I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.Version Report 23 September 2022 https://doi.org/10.21956/hrbopenres.14653.r32819© 2022 Newman C.This is an open access peer review report distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Christine Newman 1 National University of Ireland, Galway, Ireland 2 National University of Ireland, Galway, Ireland 3 National University of Ireland, Galway, Ireland

Reviewer
Report 18 August 2022 https://doi.org/10.21956/hrbopenres.14653.r32545© 2022 Dickinson F. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Fiona Dickinson 1
Liverpool School of Tropical Medicine, Liverpool, UK 2 Liverpool School of Tropical Medicine, Liverpool, UK 3 Liverpool School of Tropical Medicine, Liverpool, UK Is the rationale for, and objectives of, the study clearly described?YesIs the study design appropriate for the research question?YesAre sufficient details of the methods provided to allow replication by others?YesAre the datasets clearly presented in a useable and accessible format?YesCompeting Interests: No competing interests were disclosed.Reviewer Expertise: Development of PROMs for use in maternity services in low and middleincome countries; Emergency obstetric care in LMIC; Care of mothers and newborns in LMIC.